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Pharmaceutical machinery industry standard of the People's Republic of China JB2D039.200402004
JB/T20041~20043—2004
Hammer mill
Knife type granulating mill
Reciprocating medicine cutting machine
Medicine washing machine
Rotary medicine cutting machine
2004-02-05 Issued
2004-06-01 Implementation
National Development and Reform Commission Issued
ICS 11.120.30
Pharmaceutical machinery industry standard of the People's Republic of China JE/T20042--2004
I Y 01371993
Medicine washing machine
Herbal medicine washing machine2004-02-05 Issued
2004:06-01 Implementation
Issued by the National Development and Reform Commission
tApplication
2Hot References
3Terms and Definitions
4Classification and Marking
6Test Methods
7Inspection Room
8Marking, Packaging, Transportation and Storage
JB/F 200422004
JB/T20042-2004
This standard is based on the original standard of pharmaceutical production quality management plan (H1.12K, GR/T1.2-2002 standardization. The standard is revised for YYT0137-3 washing machine. This standard will replace YY/(1371393 from the date of its actual use. Compared with YYT01371993, the main technical changes are The following are the main changes: 1. The following are deleted and added: 2. The method specified in N/T JOI: 3. The method for determining the residual bearing equal pressure: 4.1 "Checking the sediment condition" in the main revision, the rest are as follows: 4.1. The noise detection method is changed from CB/T 13768 to the method specified in CB/T 16769: 5. The judgment rules for factory inspection are rectified as follows: If the inspection item fails, the product will be repaired and inspected. If it still fails, the product will be judged as a defective product.
The performance inspection method of the electrical case can be changed to the requirements of GR5226.1202. The customer's requirements are changed from 2 items to 8 items. c) The main items and information added are as follows:
The content of the manual (see 8.2.3):
Added factory inspection frequency change table 1:
Lubricant polish certification requirements (see 5 .2.4.6.2.4)——Application.4-1098 Inspection Equipment Quality
This standard is proposed by China Pharmaceutical Equipment Industry Association
This standard is the name of the Standardization Technical Committee of Pharmaceutical Equipment Industry: This standard is proposed by: Hebei Province Zhoukou Pharmaceutical Machinery Co., Ltd. The main drafters of this standard: Liu Zhu, Ka Tieshan, Ma Shiyu..30
1 Model
Drug washing machine
JB/T 20042—2004
This standard specifies the terms and definitions, classification and marking, requirements, test methods, test rules, marking, packaging, transportation and storage of drug washing machines.
This standard is applicable to roller-type drug washing machines.
2 Normative references
The clauses in the following documents become the clauses of this standard through reference in this standard. For all referenced documents with a date, all subsequent valid versions (excluding errata) or revisions are not applicable to this standard. However, the parties to the agreement based on this standard may study whether the revised versions of these documents can be used. For all referenced documents without a date, the latest version is applicable to this standard. （191 Packaging busy storage Tours mark
CD5226.12002 Mechanical storage Mechanical electrical equipment Part 1: General technical provisions CB/60604-19 Surface roughness Comparison of flammability Loss of gloss processing surface (FB/T6388 Transport packaging Receiving and shipping marks
GB9969.1-1998 General instructions for industrial products CB/T13306 Signs
General technical conditions for packaging of electromechanical products
GR/T13384
Metal cutting machine tools are made by the bottom level measurement and recording hall GRTJA769
YYIT control 16 Pharmaceutical machinery product plastic number compilation method 3 Terms and definitions
Selection machine herbal medicine Machina is a machine that washes and disinfects drugs by rolling, controlling, flushing, and shooting. 4 Classification and marking
4.1 The model of the washing machine is compiled according to YY/T0216
4.2 Model
The model marking consists of the product function code, type feature code and regular code, etc., 31
JB/T20042-2004
4.3 Marking example
Improved design number: in the order of A, B,
u Specification code: Condensate mutual diameter, m bZxz.net
One type feature Code: Silver Commercial Type
Product Code: Medicine Washing Machine
X1720A Type: After the first improved design, the medicine washing flow tube is 720mm / roller simple medicine washing machine. 5 Requirements
6.1 Material requirements
5,1,1 Parts in direct contact with medicines should be free of corrosion, and should not react chemically with dust or absorb medicines. 5.2 Working performance requirements
5,2.1 The operating pressure should be stable. The load time is less than 65A. 5.2.2 The reverse discharge loading and unloading are convenient, 5.2.3 The temperature of auxiliary bearings and branch channels in the operating parts should be less than 45℃ when under load. 5.2.4 The lubricating oil (grease) used in the equipment should be leak-proof. 5.2.5 The appearance is neat and smooth, the surface straightness Rz value is 1.6μm, the inner surface roughness R value is 3.2μm, and the outer cover is connected with hinges.
5.2.6 The inlet and outlet should be smooth, without overflow or water leakage. 5.3 Safety performance
5.3.1 Safety requirements for electrical systems:
5.3.1.1 The continuity of the protective grounding circuit should meet 5.3.1.2 The insulation resistance should meet the requirements of 19.3 in GB5226.1-2002, 5.3.1.3 The withstand voltage should meet the requirements of 19.4 in GB5226.1-2002. 6.3.1.4 The protective ground wire should meet the requirements of 8.2 in GB5226.1-2002. 5.3.1.5 The ground wire should meet the requirements of 10.2 in GB5226.1-2002, 5.3.1.6 The indicator light display should meet the requirements of 10.3 in GR5276.1-2002. 5.3.1.7 The electrical wiring shall comply with the provisions of Chapter 14 of (%5226.1-2X/2. 5.3.1.8 Marking, warning signs and items shall comply with the provisions of Chapter 17 of GB5226.12002. 5.3.2 Safety protection requirements:
5.3.2.1 All speed regulating machines shall have safety signs and shall not be operated in a manner that may cause accidents. 5.3.2.2 All exposed transmission parts of the machine shall be equipped with protective nets: 5.3.2.3 The location of electrical components shall be consistent with the installation requirements for waterproofing, 32
6 Test methods
6.1 Material test
Check the quality certificate of the material. If there is any objection, it should be inspected: 6.2 Performance test
Daily.2.1 Operation test: Check the load operation sense gauge and measure according to (B door T16769 and the noise value: 6, 2.2 Incoming material test: Angelica sinensis or substitute material Wu test determination: 6.2.3, Temperature test: Load operation greater than 3D)rin, use a point Meng iF to measure the bearing and bracket temperature. Lubricating oil rate seal test: After running 10mm, manually reduce, daily measurement 6.2.4
JB/T 20042—2004
6.2.5 Appearance test: According to the provisions of (Shan/T6060.4, the sample block comparison method is used to determine the appearance and inner tube simplicity. 6.2.6 Drainage channel test: Confirmation of actual operation, B.3 Safety performance test
6.3.1 Heart gas safety performance test
6.3.1.1 The continuity of the grounding circuit of the electrical system is tested according to CB5226.12002 19.2.1 respectively. 9.3.19.4 The age test is carried out as required. 8.3.1.2 The protective grounding circuit, connector, indicator light, display, wiring, label, indication mark and item code of the gas system shall be inspected in accordance with the provisions of 8.2.10.2.10.3, Chapter 14 and Chapter 17 of (15226.12X2). B.3.2 Safety protection test:
6.3.2.1 Control speed holding sign inspection: monthly test. 6.3.2.2 Protection rate network inspection: daily test. Feel its firmness. 6.3.2.3 Inspection of waterproof and tight covers of electrical components: monthly test. 7 Inspection regulations 7.1 Inspection classification: factory inspection and type inspection, 7.2 Factory inspection 7.2.1: Products shall be inspected in accordance with the requirements of Table 1, and qualified products shall be allowed to be shipped, and product certification shall be attached. Table 1 Factory Inspection Items Item Category General Function Cloud Function 7.2.2 Judgment Rules: 5.1.1. 5.2.4, 5.2.6. 5.3.1.1- 5.3.1.8 5.2.1, 5.2.2 5.2.3, 5.2.5. 5.3.1.1 5.3.1.3 If a product fails to meet certain requirements during inspection, it can be repaired and re-inspected. If the product fails to meet the requirements, it shall be judged as unqualified.
7.3 Type verification
7.3.1 Type verification should be conducted in any of the following cases: 33
TE/T20042—2004
) New products or old products; 5) When the product design, process or materials used involve major performance or major changes; e) When production is resumed after more than one year; d) When the factory inspection results are significantly different from the last type verification; e) When the national quality supervision and education agency proposes a type verification requirement. 7.3.2 Sampling:
Type verification samples should be selected from the batch of qualified machines for factory inspection, and one machine should be inspected. 7.3.9 Judgment rules:
During the type inspection, if one of the continuity, insulation resistance and withstand voltage of the protection circuit of the electrical safety performance is unqualified, it is judged that the type inspection has failed. If one of the other performance items is unqualified, the unqualified item should be retested for twice. If it still fails, the product is judged to have failed the type inspection:
8 Marking, packaging, transportation and storage
8.t Marking
8.1.1 Each unit shall be equipped with a product label as specified in the control drawing. The size and technical requirements of the label shall comply with the requirements of GR/T13306. The contents of the mark include: a) Name and model: b) Trademark: d) Power supply voltage, frequency, function; d) Manufacturer name or address: f) Factory number; g) Date of manufacture; h) Equipment weight (kg); B.1.2 The markings on the packaging box shall comply with the provisions of GB/T191 and CB/T6388. The contents of the packaging box markings include: a) Name; b) External dimensions: d) Equipment weight (kg); e) "Center of gravity", "Rainproof" and "Direction of delivery": f) "Collection" Place and unit of shipment:
6 Place and unit of shipment.
8.2 Packaging
6.2.1 The packing shall comply with the provisions of GB/T13384 and take measures to prevent moisture and moisture. 6.2.2 The packing box shall contain the following documents: a) Product certificate:
b) Packing list;
Product instructions;
|) Equipment transfer diagram:
e) Special tool list.
8.2.3 The abbreviation of the instruction manual shall comply with the requirements of GBT9.1 and the content shall include: product model, company name, address, email address and contact number b) Product label implemented:
JR/T 20042-:-2c04
) The main structure, performance, specifications, product use, scope of use, precautions, warning instructions, protective operation and product safety measures of the product:
1) Explanation of the contents of the marked graphics and symbols: e) Installation method, product repair and maintenance method, storage method. 3 Transportation
During transportation, the product should be firmly fixed on the transportation vehicle. It is strictly prohibited to roll, hit or squeeze. 8.4 Storage
The installed products should be placed steadily in the warehouse, and shall not be tilted, or allowed to be lifted or dropped. Cover with rainproof cloth when storing without any traces.
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